title: Clinical evaluation of rapid point-of-care testing for detection of novel influenza A (H1N1) virus in a population-based study in Spain.
abstract: Limited information exists on the performance of antigen-based rapid influenza diagnostic tests (RIDT) in diagnosing the novel influenza A pandemic (H1N1) 2009 virus. Large studies evaluating these tests in consecutive patients with a broad clinical spectrum of influenza-like illnesses are needed. We assessed the ClearView® Exact Influenza A & B test (Inverness Medical, Cologne, Germany) in comparison with real-time (r)RT-PCR for detection of the novel influenza A (H1N1) in a population-based prospective study of 1016 adults and children with suspected influenza in Spain. Three hundred and one (29.6%) patients had a positive sample with the rRT-PCR assay for influenza A and B viruses, with 297 (29.2%) confirmed cases of the novel influenza A pandemic (H1N1) 2009 virus. Fifty (16.8%) patients with confirmed A (H1N1) 2009 virus were admitted to hospital, with six of them to the intensive care unit. In comparison with rRT-PCR, the ClearView® Exact Influenza A & B test had a sensitivity of 19% (95% CI 14-23), a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 75% (95% CI 72-78). The sensitivity of the test remained low across all demographic and clinical strata. Although a positive RIDT performed well in predicting PCR-confirmed infection with pandemic H1N1 virus, the sensitivity was very low and a negative test result was a poor predictor of the absence of infection.
authors.affiliation: Microbiology Service, Hospital Universitario de San Juan, Alicante, Spain.
authors.forename: V Ortiz
authors.initials: VO
authors.lastname: de la Tabla
authors.forename: P
authors.initials: P
authors.lastname: Antequera
authors.forename: M
authors.initials: M
authors.lastname: Masiá
authors.forename: P
authors.initials: P
authors.lastname: Ros
authors.forename: C
authors.initials: C
authors.lastname: Martin
authors.forename: G
authors.initials: G
authors.lastname: Gazquez
authors.forename: F
authors.initials: F
authors.lastname: Buñuel
authors.forename: V
authors.initials: V
authors.lastname: Sánchez
authors.forename: C
authors.initials: C
authors.lastname: Robledano
authors.forename: F
authors.initials: F
authors.lastname: Gutiérrez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000956:Antigens, Viral / Q000097:blood*; D002648:Child; D002675:Child, Preschool; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005260:Female; D006801:Humans; D007118:Immunoassay; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology*; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D013030:Spain; D014773:Virology / Q000379:methods*; D055815:Young Adult
chemical_list: D000956:Antigens, Viral